Ulipristal meets Phase III uterine fibroid endpoints

Allergan plc (NYSE:AGN) and Gedeon Richter Ltd. (Budapest:RICHTER) said ulipristal acetate ( PGL4001) met the co-primary and secondary endpoints in the Phase III VENUS I study to treat uterine fibroids. The partners expect to complete a second Phase III study, VENUS II, in 1H17, and hope to submit an NDA next year for the selective progesterone receptor modulator (SPRM).

Compared to placebo, the study's 5 mg and 10 mg doses of ulipristal significantly improved the percentage of patients with absence of uterine bleeding and time to absence of uterine bleeding, the study's co-primary endpoints. Both doses also significantly lowered the percentage of patients with absence of uterine bleeding from day 11 to end of treatment and improved scores on a quality of life questionnaire, meeting secondary efficacy endpoints. The companies reported no treatment-related adverse events in the 157-patient study. ...